Health

FDA Overruled on Selling Morning-After Pill Without a Prescription

HHS Overrules FDA on Selling Morning After Pill Without a Prescription

Health and Human Services Secretary Kathleen Sebelius blocked over-the-counter access to the morning after pill for young teenagers Wednesday. (AP File Photo)

The Department of Health and Human Services overruled the Food and Drug Administration Wednesday, saying the morning-after pill may not be sold to young teenagers without a prescription.

As The Blaze previously reported, the FDA was prepared to make the Plan B One-Step morning-after pill available over the counter to women of all ages after a petition from the drug’s maker. Currently, only those age 17 or older can buy Plan B without a prescription. The new ruling would have let the emergency contraceptive be sold on drugstore shelves like condoms.

But Health and Human Services Secretary Kathleen Sebelius overruled her own experts at the FDA, saying in a memo to the agency she was concerned that young girls couldn’t properly understand how to use it without guidance from an adult.  The FDA had already determined the drug should be available to women of all ages without a prescription in an earlier statement Wednesday.

“It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages,” Sebelius wrote.

According to the drug’s manufacturer, Plan B can prevent pregnancy if taken within 72 hours after unprotected sex and is different from RU-486, commonly known as the abortion pill.

The Associated Press contributed to this report.

Comments (79)

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  • Ramv36
    Posted on December 7, 2011 at 10:28pm

    Having sex, protected or not, and expecting to not get pregnant really is no different than injecting heroin into your vein and being surprised you get high. Regardless of birth control method, on a long enough timeline even a 1% chance will manifest itself.
    It’s like gambling: even if the house wins 99% of the time, that still means they lose 1% of the time.

    If you ave unprotected sex you should go into it expecting to become pregnant, it’s as simple as that. If you aren’t willing to accept and be responsible for the outcomes of this action, then do not engage in the behavior, or take prudent precautions. Relationships and ‘hot & heavy in-the-moment” encounters come and go your entire life, but children are forever.

    Report Post »  
    • Ramv36
      Posted on December 7, 2011 at 10:29pm

      Oh, forgot to add: alimony and child support are also forever. Think before you act.

      Report Post »  
    • WeDontNeedNoSteenkinBadges05
      Posted on December 8, 2011 at 5:24am

      “FDA Overruled on Selling Morning-After Pill Without a Prescription”

      Is everyone enjoying the puppet show? They were just testing if they could get away with it early.
      KEEP FIGHTING BACK ANY WAY YOU CAN! MAKE THEM BACK DOWN until we kick them out.
      NEVER GIVE UP, NEVER SURRENDER!!

      Report Post » WeDontNeedNoSteenkinBadges05  
  • R.A. Bullseye
    Posted on December 7, 2011 at 10:26pm

    People have become so stupid, lazy, and empathetic that they‘ll for get to even go and get the bill and then they’ll opt for the federally funded abortion.

    Report Post »  
    • pamela kay
      Posted on December 8, 2011 at 3:11am

      I would rather see this happen than an abortion. But I have to agree that most women will not even bother with it and will instead choose abortion, especially if the tax payers foot the bill.

      Report Post » pamela kay  
  • BillnGA
    Posted on December 7, 2011 at 8:47pm

    This is a political year…….who do you think said NO?

    Report Post »  
  • Pharmer1
    Posted on December 7, 2011 at 7:58pm

    Planned Parenthood wants greater availability of Plan B because it is not very effective. There are no studies showing that increasing the availability of Plan B reduces abortion demand. The result is either no change, or increased demand for abortion.
    Sebelius has enough heat coming out of Kansas for her cozy relationships with the abortion industry. She helped cover their problems with failure to report abortions done on underage girls, etc. At this time she needs no more heat for aiding and abetting the sexual abuse of minors, something which over-the-counter Plan B facilitates.
    http://themorningafter.us/sebelius-overrules-fda-refuses-to-place-plan-b-out-on-store-shelves/

    Report Post »  
  • beenaroundyaknow
    Posted on December 7, 2011 at 6:25pm

    Bet you a paycheck that after Obama has a talk with her behind closed doors she’ll reverse her decision. It‘s all about the Chill’ren and fairness after all.

    Report Post »  
  • Raider1
    Posted on December 7, 2011 at 6:22pm

    I think the bigger question is …where do they get off using govt. agencies for political purposes. We have to abide by the rules but they can just over ride the ones they dont like?

    Report Post » Raider1  
  • LOJ
    Posted on December 7, 2011 at 5:58pm

    The Islamic Movement would like to destroy the Jewish population, and also White American populations. The Anti-Christ goals is to stop Jewish babies from being born above all, he hates God’s people. Obama belongs to his father the Devil!

    Report Post »  
  • geonj
    Posted on December 7, 2011 at 4:57pm

    i do not believe this. sebilious does the right thing. we may all not be doomed.

    Report Post » geonj  
    • TRONINTHEMORNING
      Posted on December 7, 2011 at 7:09pm

      I know, right? I had to hear and read that story again just to verify that KB actually did a good thing. But why, really?

      Report Post »  
    • KAdams
      Posted on December 8, 2011 at 7:12am

      Um.. she didn’t think 12 year olds would understand what to do without consulting a doctor. The fact that this is even available OTC is astounding…. I wasn’t even aware. Since it‘s the ’morning-after’ pill, it very obviously affects any newly fertilized egg, possibly damaging it. That would then require a D&C, or ‘termination’, since the health of the mother/child would be at risk, which would ‘justify’ any new law, that allows the procedure under duress. I can see it coming now…

      Report Post »  
  • inferno
    Posted on December 7, 2011 at 4:32pm

    People have access to birth control pills. We still have unwanted pregnancys. What makes anyone believe that the morning after pill access will decrease unwanted pregnancys ? Both will not work if not used. There is no guarantee they will work if used.

    Report Post »  
    • Locked
      Posted on December 7, 2011 at 4:42pm

      “What makes anyone believe that the morning after pill access will decrease unwanted pregnancys ?”

      Honest question: was that said in jest, or were you being serious?

      You‘re saying that it shouldn’t be available because “88-90% effective might fail?”

      The reason it shouldn’t be available is exactly what was stated: there are side effects possible from this stuff, it messes with a girl’s hormones, and the younger a girl is, the more likely they are to misuse or misunderstand it.

      Report Post »  
    • smackdown33
      Posted on December 7, 2011 at 4:52pm

      Chemical abortion pill.

      Report Post »  
  • dlivelli
    Posted on December 7, 2011 at 4:19pm

    Could there actually be someone in this administration that has a brain? No…… there must be another reason…..maybe the company would not give her a “kickback” on each pill sold so she got them back…..I don’t know…… but I find it hard to believe she did it out of logic or true concern for anyone. It may be some kind of political move so obama can say that someone on his staff made a decision that should satisfy the conservatives….etc. Then when he doesn’t get conservative support he will come back with the “no mater what I do they will never be satisfied” …..same old same old form this administration…..sad, very sad. They have no “true” morals….only responses to polls or attempts at deception to get what they want.

    Report Post »  
    • JRook
      Posted on December 7, 2011 at 4:43pm

      Couldn’t just give Secretary Sebelius and the person who appointed her credit where credit was due. You don’t think she discussed this with the President. Obviously, he did not overrule her. Yes this is the same smart person who realizes that 40 million people without health insurance is a huge drag on the economy and the rest of us. Again, a hidden tax in the form of higher fees for all payors.

      Report Post »  
    • Howsit
      Posted on December 7, 2011 at 6:43pm

      JROOK- With this administration, things are really what they appeared to be and it isn’t until later (if ever) that we see the true intentions. Sebelius has strong connections 2 abortion and usually comes down on the side of ‘more access is better.’ Given these facts, it is not hard to believe that most people are wondering what the other hand is doing. Therefore, no, they do not get the benefit of the doubt, nor any credit, because they’re history indelible he stains their credibility.

      Report Post »  
  • An_American_Thinker
    Posted on December 7, 2011 at 4:04pm

    Over-the-Counter availibility of Plan B would be extremely detrimental to future generations. Our city water supplies are already contaminated with high levels of estrogens from 40+ years of birth control pill use. The annual accumulation of Plan B hormones could eventually lead to a devastating inability of women who wish to conceive to do so.

    Report Post »  
    • KangarooJack
      Posted on December 7, 2011 at 10:34pm

      Wow! What an EXCELLENT post! You have a gift-the ability to see the commonsense angle +++future impact statements. Nice! :)

      Report Post » KangarooJack  
  • BurntHills
    Posted on December 7, 2011 at 3:55pm

    obama is also endorsing sex with animals, so this latest degeneracy coming from his communists is not surprising. OTC abortions will also bring America to a quicker close for his agenda as fewer new Americans are born. esp, there will be noticeably extremely fewer newborn black Americans. makes you really wonder who does obama hate more: the American whites or the AMERICAN blacks.

    Report Post » BurntHills  
    • encinom
      Posted on December 7, 2011 at 4:44pm

      Really, you need to stop listening to Fox news and Glenn Beck, you need to protect the few remaining brain cells you have.

      Report Post »  
  • Abraham Young
    Posted on December 7, 2011 at 3:54pm

    So which agency has more power? And why does Congress not have the power we delegated to it in the Constitution? I don’t recall contracting with any government agency to dictate terms to us. Only Congress, the representatives of the people, have any say so in any laws. Agency regulations made by petty bureaucrats don’t enter into it.

    Report Post »  
    • encinom
      Posted on December 7, 2011 at 4:49pm

      Actually, Congress tomorrow can pass a bill outlawing one drug or another. COngress has delegated power to agencies to make rules, Congress has the power to over-ride those agencies or ssues its own laws.

      Report Post »  
  • Spqr1
    Posted on December 7, 2011 at 3:28pm

    First off, most of you are so completely ignorant of basic biological science that you don’t even know how fertilization works, therefore having no clue what the difference between Plan B and RU486. And when will you all just admit it to yourselves and the world: Your real issue with such things is that you’re angry about people having sex because of disfunctional sexual repression. Sit down, take a deep breath, relax and realize that contraceptives can actually PREVENT abortions. Come into the rational, reality based world and accept the observable fact that you will NEVER stop people from having sex…….

    Report Post »  
    • deeberj
      Posted on December 7, 2011 at 3:42pm

      You are the ignorant one. RU486 is obviously an abortifacient.

      Read this about Plan B.
      http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109795.htm

      From that site, please note the fourth sentence. This is an abortafacient also.
      “Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.”

      Report Post » deeberj  
    • Locked
      Posted on December 7, 2011 at 3:57pm

      @Deeberj

      “therefore having no clue what the difference between Plan B and RU486.”
      “You are the ignorant one. RU486 is obviously an abortifacient.”

      It seems like you misread: he said there’s a difference between the two. This is true.

      RU486 destroys an implanted zygote or fetus, dislodges it from the uterine wall, and ejects it. Plan B stop ovulation and thickens the uterine lining which may stop implantation; an egg, fertilized or not, will be ejected during the normal monthly menses.

      One is an abortion, the other is not. One destroys an implanted, fertilized egg; the other stops the egg from being fertilized and may stop implantation if it is.

      Report Post »  
    • Spqr1
      Posted on December 7, 2011 at 6:18pm

      Read again, this time for CONTENT……..

      Report Post »  
    • Spqr1
      Posted on December 7, 2011 at 6:19pm

      PS, try actually addressing the real issue.

      Report Post »  
    • Ramv36
      Posted on December 7, 2011 at 10:16pm

      “Come into the rational, reality based world and accept the observable fact that you will NEVER stop people from having sex…….”

      I agree, and you could call me pro-choice: I believe that if you consent to having sex, unprotected or not, you tacitly agree to committing an act that is designed to cause pregnancy, and both partners agree to shoulder the responsibilities and consequences of this act.

      Having sex casually with no mind to the biologically intended consequences of said act is no different than smoking marijuana and being surprised that you get high.

      Report Post »  
    • proud2bmom
      Posted on December 8, 2011 at 8:48am

      Life begins at conception. Since the Plan B pill inhibits implantation (which occurs after fertilization) it is by definition an abortion pill. It may work differently than RU486, but they both achieve the same results.

      Report Post »  
    • Spqr1
      Posted on December 8, 2011 at 2:55pm

      Do none of you know the whole “life begins at conception” is nothing more than a late-20th C, GOP talking point?

      Report Post »  
  • disenlightened
    Posted on December 7, 2011 at 2:47pm

    Kathleen Sebelius, the Angel of Death, must be sooooooo upset. She won’t sleep a wink tonight thinking of another way to kill children so easily and cheaply.

    Report Post » disenlightened  
    • meskew
      Posted on December 7, 2011 at 3:21pm

      Let the woman decide what is best. If the pill prevents ovulation, thus pregnancy, then all of you confused individuals out there should not be confused any longer. People are going to have sex. Period. This way they do not have to worry about the consequences of an unwanted pregnancy since the pregnancy never happened. Best pill I have seen since Viargra hit the shelves!

      Report Post »  
    • Spqr1
      Posted on December 8, 2011 at 2:56pm

      Letting a woman decide? Yeah, like these people would EVER agree to that concept out loud.

      Report Post »  
  • proud2bmom
    Posted on December 7, 2011 at 2:40pm

    From the Mayo Clinic’s website: “The morning-after pill can be used after you’ve had unprotected sex. Depending on where you are in your menstrual cycle, the morning-after pill can prevent or delay ovulation, block fertilization, or keep a fertilized egg from implanting in the uterus. Don’t take the morning-after pill if you’re already pregnant.”

    If it does nothing to an existing pregnancy, as some of you have stated, then why does it say not to take it if you are pregnant? This IS another form of an abortion pill, even if it works differently than RU486.

    Report Post »  
    • Locked
      Posted on December 7, 2011 at 2:48pm

      It’s because it floods your system with hormones. While it won’t induce an abortion, it’s possible there may be effects such as birth defects or influences upon the zygote (such as influencing the sex of the child by flooding it with estrogen).

      It‘s the same reason you wouldn’t take regular birth control during pregnancy. It won’t cause an abortion, but additional hormones may cause side effects.

      Report Post »  
    • deeberj
      Posted on December 7, 2011 at 3:44pm

      Locked you are wrong. Plan B also prevents implantation of a fertilized egg. It‘s on the gov’t web site about this new ruling.

      Report Post » deeberj  
    • Locked
      Posted on December 7, 2011 at 3:50pm

      @Deeber

      I‘m not sure where I was wrong in the comment you’re responding to. It may prevent implantation, but the main action is to stop ovulation. The implantation part is under debate, as studies show it may thicken the uterus but does not stop implantation.

      If implantation has occurred, a Plan B cannot abort the zygote. Again, it’s not an abortion pill.

      Report Post »  
    • proud2bmom
      Posted on December 8, 2011 at 8:50am

      @ Locked, by preventing implantation it is by default causing an abortion!

      Report Post »  
  • lylejk
    Posted on December 7, 2011 at 1:58pm

    It might have been for political reasons; time will tell, but finally a decision from this woman that I can actually agree with. :)

    Report Post » lylejk  
  • Mandors
    Posted on December 7, 2011 at 1:52pm

    Please, this is nothing but kicking an explosive issue down the road during an election cycle. Approving a new abortion pill for minors to use? That would be an instant RNC commercial. If Barry gets reelected, there is a 100% chance Sebelius will reverse herself–citing the experts.

    Report Post » Mandors  
    • Locked
      Posted on December 7, 2011 at 1:55pm

      This isn’t the abortion bill. It prevents ovulation, it doesn’t induce abortion. If ovulation has already occurred, pregnancy is extremely likely; hence why there’s a 72 hour window.

      Report Post »  
    • ICRedifURBlue
      Posted on December 7, 2011 at 2:23pm

      It’s OK baby….we don’t need protection, just eat one of these………….OR….sure baby we can try to get pregnant (but I ain‘t gonna tell ya’ about the pill in your coffee in the morning)………..

      Report Post »  
    • biohazard23
      Posted on December 7, 2011 at 2:35pm

      Locked,

      It prevents implantation of a fertilized egg. BCPs inhibit ovulation.

      Report Post » biohazard23  
    • Mandors
      Posted on December 7, 2011 at 2:45pm

      LOCKED, what if the woman is already ovulating? She then takes the pill three days later. Hmm. What happens then to “prevent” pregnancy?

      Report Post » Mandors  
    • Locked
      Posted on December 7, 2011 at 2:46pm

      @BIO

      Not sure what you mean by BCP. ECP (Emergency Contraceptive Pills) work by preventing ovulation. Studies show that it’s unlikely that they are effective at stopping implantation; the reason for the small time window of effectiveness is because they stop ovulation so an egg cannot be fertilized.

      Report Post »  
    • Locked
      Posted on December 7, 2011 at 2:50pm

      @Mandors

      She gets pregnant. Hence why it’s not effective after 72 hours, and before then it’s only an 88-90% effectiveness rate.

      Report Post »  
    • Ramv36
      Posted on December 7, 2011 at 10:20pm

      “Approving a new abortion pill for minors to use? That would be an instant RNC commercial.”

      Personally I’m itching to see what I expect will be a SLEW of RNC commercials hammering the UCMJ Article 125 repeal allowing sodomy/bestiality in the Armed Forces.

      If they don’t put a reference to that passed law in every other commercial, well, they’re complete idiots in my book.

      Report Post »  
  • DrillSgt
    Posted on December 7, 2011 at 1:48pm

    I wonder if Planned Parenthood had any influence on the HHS decision. I mean, if they can’t coerce young girls into getting an abortion, how much $$$$ would they lose?

    Report Post »  
  • iblvingd
    Posted on December 7, 2011 at 1:41pm

    Does it seem like the government and all its NGO’s are thinking way too much about sex lately? What is going on in those meetings?

    Report Post »  
  • TEIN
    Posted on December 7, 2011 at 1:41pm

    Wow!!! So, in a round-about-way Secretary Kathleen Sebelius is admitting that there are activities that young teens are not mentally or emotionally ready to handle..

    Report Post »  
    • Ruler4You
      Posted on December 7, 2011 at 1:45pm

      There must be a stipulation that gets the FDA a certain percentage of sales receipts these days.

      The FDA is now a for profit AND tax payer funded entity. As well as an extortion racket in the pharmaceutical industry.

      Report Post » Ruler4You  
  • Khedewia
    Posted on December 7, 2011 at 1:38pm

    I don’t think it should be available at all, but at least Kathleen Sebelius made the right decision here. I am so surprised.

    Report Post »  
  • Obama Snake Oil Co
    Posted on December 7, 2011 at 1:36pm

    Murder in pill form…..

    Report Post » Obama Snake Oil Co  
    • Locked
      Posted on December 7, 2011 at 1:57pm

      I assume you consider condoms murder as well…? Plan B prevents ovulation; it cannot abort a pregnancy.

      Report Post »  
    • Obama Snake Oil Co
      Posted on December 7, 2011 at 2:22pm

      Its what the Pope considers as birth control….yes.

      Report Post » Obama Snake Oil Co  
    • Locked
      Posted on December 7, 2011 at 2:35pm

      I‘m not even sure what that’s supposed to mean, unless you‘re saying you’re a fundamentalist Catholic and sex without a chance for reproduction is a sin?

      Even then, it’s not “murder” in any sort of way, just your regular venial sin, so you’d still be incorrect.

      Report Post »  
    • deeberj
      Posted on December 7, 2011 at 3:45pm

      Locked is wrong.

      Report Post » deeberj  
    • Locked
      Posted on December 7, 2011 at 3:59pm

      @Deeberj

      Explain how. Abortion kills an implanted, fertilized egg. Plan B prevent fertilization and may stop implantation (although implantation can still occur; it’s just less likely).

      Report Post »  
    • NEVER.GIVE.IN
      Posted on December 7, 2011 at 10:19pm

      @ locked: Consider this perspective. A “fertilized egg” is a person. A biologically discrete individual. Intentionally putting that person in a hostile environment (uterine and mucus changes) constitutes negligence at the least, and murder at the worst. It is morally akin to a toddler falling in a swimming pool: they cannot swim or climb out, and so they die. Someone is at fault for endangering both children.

      Report Post »  
    • KAdams
      Posted on December 8, 2011 at 7:24am

      @Locked:

      Definition of abort, and by extension: abortion:
      a·bort[uh-bawrt]
      verb (used without object)
      1.to bring forth a fetus from the uterus before the fetus is viable; miscarry.
      2.to develop incompletely; remain in a rudimentary or undeveloped state.
      3.to fail, cease, or stop at an early or premature stage.
      4.Military . to fail to accomplish a purpose or mission for any reason other than enemy action.
      5.Rocketry . (of a missile) to stop before the scheduled flight is completed.

      I would say that #3 could qualify Plan B as being an ‘abortion’ pill. If Plan B prevents ovulation, then #3 could apply, since the menses is a cycle, a continuous thing.

      Report Post »  
  • Gonzo
    Posted on December 7, 2011 at 1:36pm

    A rational thought …from that woman? Wake me up.

    Report Post » Gonzo  
    • Mandors
      Posted on December 7, 2011 at 1:49pm

      No, a politically expedient time to use reality as an excuse during an election cycle. If Barry wins, I got a buck that says Sebelius will reverse her position faster than Barry goes on vacations.

      Report Post » Mandors  
    • Stoic one
      Posted on December 7, 2011 at 2:04pm

      MANDORS
      I bet she changes her mind on Weds, November 7, 2012.

      Report Post » Stoic one  
  • hauschild
    Posted on December 7, 2011 at 1:36pm

    Ha – look at the Marxists suddenly “finding religion” as election time draws near.

    Report Post »  
    • thekuligs
      Posted on December 7, 2011 at 1:45pm

      UGH in DROVES they seem to be finding religion. More so than usual.

      Report Post » thekuligs  
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